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Brand Name :
Gas Relief Extra Strength, Gas-X Extra Strength, Infants Gas Relief, Phazyme Maximum Strength, Phazyme, Teeny Tummy Gas Relief Drops, Gas Relief Extra Strength, Gas-X Childrens, Heartland Gas Relief [OTC]
Synonyms :
simethicone
Class :
Gastrointestinal; Anti flatulent
Dosage Forms & Strengths
Capsule
125mg
180mg
250mg
Oral Liquid
20mg/0.3ml
Oral Suspension
20mg/0.3ml
Chewable Tablet
80mg
125mg
40-125 mg orally 4 times each day as required
post-meals at bedtime
Administer a single dose in a range of 160-500 mg post-meals at bedtime
Do not exceed the maximum dose of more than 500 mg each day
Dosage Forms & Strengths
Capsule
125mg
180mg
250mg
Oral Liquid
20mg/0.3ml
Oral Suspension
20mg/0.3ml
Chewable Tablet
80mg
125mg
Refer to the adult dosing
Actions and Spectrum
Black Box Warning:
None
Contraindication/Caution:
Pregnancy consideration:
Pregnancy Category: C
Breastfeeding warnings:
It is not excreted in the breast milk.
Pregnancy category:
Category A: Well-controlled and satisfactory studies show no risk to the fetus in the initial or later trimester.
<b>Category B: There was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: There was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence, these categories of drugs need to be avoided by pregnant women.
Category N: No data is available for the drug under this category.
Pharmacology:
Pharmacodynamics:
Pharmacokinetics:
Absorption
simethicone is not absorbed into the bloodstream to a significant extent. When taken orally, it remains in the gastrointestinal tract and does not enter systemic circulation. This is because simethicone is not absorbed through the intestinal walls into the bloodstream and acts locally to address gas-related symptoms.
Distribution
simethicone does not distribute throughout the body’s tissues and organs because it does not enter the bloodstream. Instead, it remains in the digestive tract, where it exerts its effects on gas bubbles and foam.
Metabolism
simethicone does not undergo metabolic processes in the body. It remains chemically unchanged and does not produce active metabolites.
Elimination and Excretion
simethicone is excreted from the body primarily through feces. Since it is not absorbed into the bloodstream, it does not undergo renal elimination via the kidneys. Instead, it is eliminated in its unchanged form via the gastrointestinal tract.
Administration:
Patient information leaflet
Generic Name: simethicone
Pronounced as: sy-meth-i-kone
Why do we use simethicone?